None listed
Conditions
Brief summary
This study will evaluate the safety and clinical effectiveness of the M-Finity femoral stem used in total hip arthroplasty. This will be achieved by assessing survivorship and collecting patient reported outcome measures from patients receiving the M-Finity stem. Patient clinical and radiographic outcomes will be analysed pre-implantation and post-implantation through to 2 years and clinical outcomes continued to 10 years. The survivorship data will be compared to the cementless stems currently on the market using the Australian Orthopaedic Association National Joint Registry (AOANJRR) data. The hypothesis is that the 2-year cumulative percent revision of the M-Finity cementless femoral stem is not inferior to the performance of other femoral stems currently on the Australian market.
Interventions
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The M-Finity femoral stem is an implant designed for THA. The implant is designed to provide a good fit and stability. Each participant will receive the new Medacta M-Finity femoral stem device together with a compatible Medacta Acetabular Cup, as part of r
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The M-Finity femoral stem is an implant designed for THA. The implant is designed to provide a good fit and stability. Each participant will receive the new Medacta M-Finity femoral stem device together with a compatible Medacta Acetabular Cup, as part of routine treatment for total hip replacement procedures. These devices will be implanted by qualified and experienced orthopaedic surgeons as per routine practice. The duration of the procedure will take approximately 1-1.5 hours, as per a standard THA. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 3 months, 1 year, 2 years, 5 years and 10 years time points post-procedure. Routine x-rays will be analysed at 3 months, 1 year, 2 years, 5 years and 10 years timepoints post-procedure to investigate the radiological performance of the implant in terms of implant placement.
Sponsors
Medacta Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a primary total hip replacement and are suitable for cementless femoral neck preserving stem according to the indications for use (On-Label use). * BMI less than or equal to 40. * Skeletally mature adults aged 18 years and over at the time of registration. * Ability to give informed consent. * Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Exclusion criteria
* The subject is classified as morbidly obese (BMI greater than 40) * Active infection within the affected hip joint. * Previous total hip replacement or hip fusion of the affected hip joint. * Intra-articular fracture * Neuromuscular or neurosensory deficiency which limits the ability to evaluate the safety and effectiveness of the device. * Diagnosed metabolic disorder which may impair bone formation or bone quality (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy) * Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. * Workers’ compensation patients or currently in any injury litigation claims
Outcome results
None listed